Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval for IMAAVY (nipocalimab-aahu) to treat warm autoimmune hemolytic anemia (wAIHA). This is the first therapy proven safe and effective for this rare autoantibody disease in adults and children aged 12 and older.
The FDA issued the approval under Priority Review based on a pivotal Phase 2/3 study. Results showed a durable hemoglobin response and improved fatigue scores for patients using the treatment.
IMAAVY is an immunoselective FcRn blocker that reduces pathogenic IgG autoantibodies. These antibodies cause the immune system to destroy red blood cells, resulting in severe anemia and fatigue.